Clinical Trial Manager – FSP
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Job Description
Clinical Trial Manager overseeing low- to moderate-complexity clinical studies for Thermo Fisher Scientific in Mexico. Managing monitoring, regulatory submissions, trial deliverables, resources, timelines, and quality.
Responsibilities:
- Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
- Assume Clinical Study Manager responsibilities on small or less complex projects when required
- Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans
- Set up, organize, maintain, and archive Trial Master File sections and study materials
- Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
- Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings
- Collaborate with clinical teams and other departments to meet project deliverables
- Lead team meetings and maintain timelines, resources, interactions, and quality
- Implement and train teams on standardized clinical monitoring processes
- Prepare and monitor clinical timelines and metrics; provide status updates and implement recovery actions
- Review monitoring visit reports and manage CRF collection and query resolution
- Monitor or co-monitor clinical trials and conduct Accompanied Field Visits when required
- Communicate with study sites regarding protocols, patient participation, CRF completion, and related issues
- Coordinate study start-up activities and ethics committee and regulatory submissions
- Review ethics committee questions and ensure essential document quality
- Provide input to clinical activity forecasts and manage clinical resources, responsibilities, and additional resource needs
- Ensure final clinical deliverables meet contractual time, quality, and cost expectations while maintaining profitability
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years of comparable experience
- Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
- Leadership, mentoring, training, and team motivation skills
- Planning and organizational skills
- Interpersonal and problem-solving skills in a multicultural matrix organization
- Ability to work effectively in changing environments with complex or ambiguous situations
- Familiarity with clinical monitoring practices, processes, and requirements
- Judgment and decision-making skills
- Effective oral and written communication skills, including English language proficiency
- Ability to evaluate workload against project budget and adjust resources
- Financial acumen and knowledge of budgeting, forecasting, and fiscal management
- Strong attention to detail
- Understanding of relevant regulations, including ICH/GCP and FDA guidelines
- Computer skills using Outlook, Excel, Word, and similar applications
- Frequent domestic and international travel
Benefits:
- Fully remote work mode
- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused work environment
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